a study to test the safety and tolerability of staccato alprazolam in study participants 12 years of age and older with stereotypical prolonged seizures

Conditions: Stereotypical Prolonged Seizures

Summary: the purpose of the study is to evaluate the long-term safety and tolerability of staccato alprazolam.


Eligibility criteria:
inclusion criteria: * participant must be ≥12 years of age at the time of signing informed consent * participant must have a study caregiver ≥18 years of age at the time of signing the informed consent; the study caregiver(s) must be able to recognize and observe the participant's seizures * participants with an established diagnosis of focal or generalized epilepsy or combined focal and generalized epilepsy with a documented history of stereotypical episodes of prolonged seizures that includes at least 1 of the following: 1. generalized seizure episodes starting with a flurry of absence seizures or myoclonic seizures with a minimum total duration of 5 minutes 2. episodes of a focal seizure with a minimum duration of 3 minutes 3. episodes of a focal seizure or a flurry of myoclonic seizures for at least 90 seconds followed by a generalized/bilateral tonic-clonic seizure with a minimum total duration of 3 minutes * prior to the screening visit, participant completed a study using staccato alprazolam (such as ep0162 (nct05077904), engage-e-001 (nct03478982), or up0100 (nct04857307)) exclusion criteria: * participant has a current history of alcohol or drug use disorder, as defined in the diagnostic and statistical manual of mental disorders 5, within the previous 1 year * participant has a known hypersensitivity to any components of the investigational medicinal product (imp) or comparable drugs (and/or an investigational device) as stated in this protocol or to albuterol (or similar bronchospasm rescue medication if needed to meet country-specific requirements) * participant has a history of convulsive (generalized tonic-clonic) status epilepticus in the 8 weeks prior to the screening visit * participant has a history or presence of known nonepileptic seizures which cannot be distinguished from qualifying epileptic seizures * participant has a clinically significant known airway hypersensitivity (eg, bronchospasm to known allergens, such as pollen, animals, or food) and/or acute respiratory signs/symptoms (eg, shortness of breath, wheezing on lung auscultation). note: participants with mild asthma who qualify for inclusion in the are allowed to be enrolled even though they have known airway hypersensitivity * participant has a clinically significant chronic pulmonary disorder other than mild asthma (eg, chronic obstructive pulmonary disease, restrictive lung diseases \[including idiopathic pulmonary fibrosis\]) and/or recent history or presence of hemoptysis or pneumothorax * participant has had a positive antigen test for severe acute respiratory syndrome coronavirus 2 (sars-cov-2) and experienced moderate to severe signs/symptoms of respiratory distress necessitating hospitalization or outpatient treatment such as ambulatory oxygen, extensive treatment with inhaler medications, and/or oral medications for a duration of 4 weeks or more, unless full resolution occurred at least 6 months prior to screening * participant has experienced a severe upper respiratory tract infection within 4 weeks or severe bronchitis/pneumonia within 3 months before the screening visit * participant has a history or presence of acute narrow-angle glaucoma * participant has a condition for which oral alprazolam is contraindicated * participant is taking any drug that is a strong cyp3a4 inhibitor, including azole antifungal agents (ketoconazole and itraconazole) and nefazodone * participant is taking any opioids or sedative hypnotics on a chronic basis * participant is taking nonselective beta blockers on a chronic basis

Keywords: stereotypical prolonged seizures phase 3 staccato alprazolam